Specialist I, QMS

Location
Gaithersburg, MD, US
Posted
Aug 26, 2020
Ref
663632800
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

JOB SUMMARY

Reporting to the QMS Manager, Device Quality, the QMS Specialist, Device Quality, will assist with oversight of Device Quality systems such as Training, Document Control, Management Review, Stability, Annual Reports, Risk Management, Risk Registry, Change Management, Deviations, CAPAs, and ensure appropriate alignment to the Global Quality Management System.

The QMS Specialist will assist in maintaining a system for centralized Quality Device metrics data collection, analysis, trending and reporting to identify opportunities and drive continuous improvement.

The QMS Specialist will interact with all members across all sites to achieve uniformity and consistency in quality systems at the Device Business Unit levels and promote Emergent's core values and accountability through words and actions.

ESSENTIAL FUNCTIONS
  • Serve as training system administrator for Device Business Unit
  • Define user requirements for Device Training curriculum and ensure alignment of job curricula with job descriptions
  • Design and develop course curriculums for Device Business Unit and ensure harmonization with Global Quality Standards
  • Process Learning Management System (LMS) access and training assignment requests
  • Ensure consistency in curricula implementation at the sites
  • Assist with implementation of computerized training modules
  • Establish and maintain training metrics
  • Remain current with global and industry training standards and practices
  • Represent Device Quality in global GxP training meetings
  • Implementation and administration of e-Docs for Device Business Unit
  • Author and execute tasks for document revisions, deviations, CAPAs, and change controls related to the Device QMS system performance
  • Assist with harmonization of Device Business Unit SOPs and ensure alignment with global quality standards
  • Support Device Business Unit system administration for the following quality management systems:
    • Change Control Process
    • Device Quality Manual
    • Device Quality Management Review
    • Maintenance of Device Documents
    • Trending of system performance with metrics
    • Periodic Review administration and oversight
    • Risk Management
    • Risk Register
    • Internal Audits
    • Multi-site Deviations, CAPAs and Change Controls
    • New Employee Guide for Device Business Unit
    • Assist with audits by external parties, including regulatory agencies, by providing strategic guidance and subject matter expertise
    • Identify opportunities for improvement within scope of work
    • Ensure compliance with current Good Manufacturing Practices, OSHA, USDA, applicable ISO standards and other areas of mandatory regulatory oversight
    • Responsible for identifying defects and have the authority to report device defects at any time


The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
  • BA/BS degree (preferably in an Applied Science) or equivalent work experience
  • Minimum of 5 years of experience working in a cGMP manufacturer, Aseptic Manufacturing, or Medical Device Manufacturing company
  • Previous experience working with FDA/EU and participating in regulatory agency inspections preferred
  • Experience with designing and developing course content, including web-based training
  • Experience with electronic learning management, electronic document management, deviation, CAPA, and change control systems
  • Proficient in understanding of training procedures and techniques (i.e. training facilitation, presentation skills, and curriculum development)
  • Must have SOP and investigation writing skills and demonstrated ability to critically evaluate content of such documents
  • Strong oral and written communication skills
  • Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations
  • Ability to work independently and in a team setting with minimal supervision


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
  • There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job.
  • This information is available upon request from the candidate.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.


Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.